Lactobacillus Brevis CD2 Preventing Oral Mucositis

Mucositis Clinical Trial

Official title:

A Pilot Study on the Efficacy of Lactobacillus Brevis CD2 Lozenges in Preventing Oral Mucositis by High-dose Chemotherapy With Autologous Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02085694
• Other study ID #: 001/14
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 6, 2014
• Last updated: March 8, 2014
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2014
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

A pilot study on efficacy of Lactobacillus CD2 lozenges in preventing oral mucositis (OM) by high-dose chemotherapy with autologous hematopoietic stem cell transplantation. To test whether the probiotic Lactobacillus brevis CD2 lozenges can reduce the incidence and severity of high-dose chemotherapy conditioning regimen induced OM in patients undergoing HSCT.

Clinical activity will be defined as reduction in the incidence of chemotherapy induced OM in the patients undergoing HSCT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 65 years

• Karnofsky Performance Score = 70%.

• Confirmed histological diagnosis of multiple myeloma for which HSCT is as approved modality of therapy

• Patients eligible to receive high-dose chemotherapy as part of conditioning regimen

• Concomitant co morbid condition if present, controlled by ongoing treatments (e.g. hypertension, diabetes and so on)

• Serum creatinine < 1.8mg/dl

• Total bilirubin < 2mg/dl

• Liver enzymes within three times of normal limit

• Expected survival > 6 months.

Exclusion Criteria:

• Pregnant women and lactating mothers

• Patients with history of HIV infection

• Patients who have taken any other investigational product in last 4 weeks

• Patients having untreated symptomatic dental infection

• Patients with WHO Grade 3 or 4 oral Mucositis

• Other serious concurrent illness

• Inconclusive hematological diagnosis

• Patients with signs and symptoms of systemic infections

• Patient's/guardian's refusal to sign informed consent

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mucositis
• Stomatitis

Intervention

Drug:
• Lactobacillus brevis CD2

Locations

Country	Name	City	State
Italy	Policlinico Universitario "A. GEMELLI"	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) for evaluation of change in oral mucositis		days -14;-7; 0;+7;+14;+21	No
Secondary	COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) to determine the incidence of Grade I and II OM		days -14;-7; 0; +7;+14; +21	No